NCT00062127

Brief Summary

Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

June 5, 2003

Last Update Submit

January 23, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (4)

  • Effect of thalidomide on irinotecan hydrochloride pharmacokinetics

    Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours

  • Effect of irinotecan hydrochloride on thalidomide pharmacokinetics

    Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 and 168 hours

  • Grade 3 or greater toxicities assessed using NCI CTC version 2.0

    Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.

    Up to 3 years

  • Response assessed using RECIST criteria

    Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.

    Up to 3 years

Study Arms (2)

Arm I (irinotecan hydrochloride and thalidomide)

EXPERIMENTAL

Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: irinotecan hydrochlorideDrug: thalidomideOther: pharmacological study

Arm II (irinotecan hydrochloride and thalidomide)

EXPERIMENTAL

Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: irinotecan hydrochlorideDrug: thalidomideOther: pharmacological study

Interventions

irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Arm I (irinotecan hydrochloride and thalidomide)Arm II (irinotecan hydrochloride and thalidomide)
thalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Arm I (irinotecan hydrochloride and thalidomide)Arm II (irinotecan hydrochloride and thalidomide)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I (irinotecan hydrochloride and thalidomide)Arm II (irinotecan hydrochloride and thalidomide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignant solid tumor
  • Metastatic or unresectable
  • Standard curative or palliative therapy is no longer effective or does not exist
  • Measurable or assessable disease
  • No uncontrolled brain metastases
  • Patients with brain metastases are eligible provided the following are true:
  • Stable neurologic status
  • At least 4 weeks since prior steroids or anticonvulsants
  • No neurologic dysfunction that would confound evaluation
  • Performance status - Karnofsky 70-100%
  • More than 12 weeks
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin normal
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Interventions

IrinotecanThalidomide

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mark Ratain

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

April 1, 2003

Primary Completion

May 1, 2006

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)